BACKGROUND:Target lesion revascularization (TLR) with primary percutaneous transluminal angioplasty (PTA) versus cryoplasty (CRYO) in the treatment of de novo femoropopliteal disease has not been well defined in randomized trials. METHODS: In this prospective, 2-center randomized trial of PTA vs CRYO of femoropopliteal arteries, the primary endpoint of TLR was evaluated at 6 months. Secondary endpoints included the rate of bail out stenting because of suboptimal acute angiographic results (defined as a residual narrowing of ≥30% or type C or higher dissection) and target vessel revascularization (TVR). Major adverse events including death and amputations were recorded. A two sample t test was used to compare the two groups on the continuous variables. For categorical variables, cross tabular analysis was conducted with nonparametric tests (Chi Square and Fisher's Exact) used to test for significant differences. RESULTS:A total of 40 patients were included in the study. Of these 20 patients (24 vessels) were included in the PTA arm and 20 patients (26 vessels) in the CRYO arm. CRYO was performed at a predefined automated pressure of 8 atm. PTA was performed at a mean pressure of 9.57±1.34 atm (P=.001 compared to CRYO). TLR (10.5% vs. 15%, P=NS) and TVR (10% vs 25%, P=NS) were statistically similar between the PTA arm compared to the CRYO arm respectively. Bail out stenting was performed in 10/24 (41.7%) of vessels in the PTA arm and 10/26 (38.5%) of patients in the CRYO arm (P=NS). CONCLUSION: In this pilot randomized study of de novo femoropopliteal lesions, CRYO and PTA had the same TLR and TVR at 6 months in treating femoropopliteal de novo lesions. Also, bail out stenting was statistically similar between the 2 groups. Larger studies are needed to confirm these results.
RCT Entities:
BACKGROUND: Target lesion revascularization (TLR) with primary percutaneous transluminal angioplasty (PTA) versus cryoplasty (CRYO) in the treatment of de novo femoropopliteal disease has not been well defined in randomized trials. METHODS: In this prospective, 2-center randomized trial of PTA vs CRYO of femoropopliteal arteries, the primary endpoint of TLR was evaluated at 6 months. Secondary endpoints included the rate of bail out stenting because of suboptimal acute angiographic results (defined as a residual narrowing of ≥30% or type C or higher dissection) and target vessel revascularization (TVR). Major adverse events including death and amputations were recorded. A two sample t test was used to compare the two groups on the continuous variables. For categorical variables, cross tabular analysis was conducted with nonparametric tests (Chi Square and Fisher's Exact) used to test for significant differences. RESULTS: A total of 40 patients were included in the study. Of these 20 patients (24 vessels) were included in the PTA arm and 20 patients (26 vessels) in the CRYO arm. CRYO was performed at a predefined automated pressure of 8 atm. PTA was performed at a mean pressure of 9.57±1.34 atm (P=.001 compared to CRYO). TLR (10.5% vs. 15%, P=NS) and TVR (10% vs 25%, P=NS) were statistically similar between the PTA arm compared to the CRYO arm respectively. Bail out stenting was performed in 10/24 (41.7%) of vessels in the PTA arm and 10/26 (38.5%) of patients in the CRYO arm (P=NS). CONCLUSION: In this pilot randomized study of de novo femoropopliteal lesions, CRYO and PTA had the same TLR and TVR at 6 months in treating femoropopliteal de novo lesions. Also, bail out stenting was statistically similar between the 2 groups. Larger studies are needed to confirm these results.